Determinants of Onset and Progression of COPD in Young Adults

COPD Clinical Trial

— EARLY COPD  

Official title:

Early COPD: Determinants of Onset and Progression of COPD in Young Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02352220
• Other study ID #: PI13-02225
• Status: Active, not recruiting
• Phase: N/A
• First received: December 2, 2014
• Last updated: February 24, 2018
• Start date: January 2015
• Est. completion date: December 2020

Study information

• Verified date: February 2018
• Source: Hospital Son Espases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

COPD (Chronic Obstructive Pulmonary Disease) is a Public Health problem due to its impact in the patient's quality of life, high prevalence, growing incidence and socioeconomic implication. COPD natural history and first stages determinants are unknown. Knowing them will help to understand the natural history of the disease and to design interventions that can modify the prognosis of the disease.

Study objectives: (1) To characterize an early COPD population from a multidimensional point of view including demographic, social, family and clinical data, lung function, exercise capacity, image, microbiology, quality of life, exacerbations, comorbidities and blood and sputum biomarkers. (2) To compare this patients with smoking subjects, with normal lung function, matched by age, sex and site. (3) To create an early COPD cohort to be followed in the future to understand the complete natural history of the disease.

Methods: Design: multicenter cross-sectional study that will allow establishing a well-characterized cohort of early COPD patients for later follow-up. Recruitment will be done in Primary Care settings. Subjects: smokers (> 10 packs year) between 35-50 years old with a spirometry (normal or obstructive) done in the last year. Diagnosis of COPD will be based on the smoking history and a postbronchodilator test FEV1(Forced Expiratory Volume in the first second) / FVC(Forced Vital Capacity) < 70%. Age, sex and site matched 'healthy' smoker controls will be compared with the COPD cases. Variables that will be collected in the reference hospitals are: health questionnaires, lung function test, exercise capacity, blood and sputum samples, and low dose CT-scan. Statistical analysis: early COPD patient's characteristics will be described and then, will be compared, with control subjects through a conditional multiple logistic regression analysis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

**Inclusion Criteria:

COPD case:

• Subjects between 35 and 50 years

• Post-bronchodilator spirometry with FEV1/FVC <70%

• Smoker or ex-smoker with total cumulative exposure > 10 pack-years

Smoking control:

• Subjects between 35 and 50 years

• Post-bronchodilator spirometry with FEV1/FVC >=70%

• Smoker or ex-smoker with total cumulative exposure> 10 pack-years

• Exclusion Criteria:

For cases:

• Chronic inflammatory diseases including autoimmune diseases under treatment.

• HIV

• Active cancer

• Cystic or saccular bronchiectasis

• Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia…

For controls:

• Chronic inflammatory diseases including autoimmune diseases under treatment

• HIV

• Active cancer

• Chronic respiratory diseases:

• active tuberculosis

• interstitial lung diseases

• cystic or saccular bronchiectasis

• ever diagnosed asthma

• deficit of alpha1-antitrypsin

• Conditions that may interfere with follow-up: frequent change of residence, psychiatric disorders, dementia …

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
Spain	Hospital Son Espases	Palma Mallorca	Mallorca

Sponsors (16)

Lead Sponsor

Collaborator

Borja Cosio

Boehringer Ingelheim, Centre for Research in Environmental Epidemiology, Spain, Hospital Arnau de Vilanova, Hospital Clinic of Barcelona, Hospital del Mar, Hospital Parc Taulí, Sabadell, Hospital Son Espases, Hospital Universitari de Bellvitge, Hospital Universitario 12 de Octubre, Hospital Universitario Central de Asturias, Hospitales Universitarios Virgen del Rocío, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Spanish Research Center for Respiratory Diseases, University Hospital A Coruña, University Hospital of the Nuestra Señora de Candelaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in lung function measures between cases and controls		At time of visit 1 (cross-sectional)